Comparing Methylprednisolone Injections to Placebo for Treating Vertigo in Meniere's Disease
Official title: A Multicenter, Double-blinded, Randomized, Placebo-controlled Trial to Compare the Effectiveness of Intratympanic Injections methylPREDnisolon Versus Placebo in the Treatment of Vertigo Attacks in MENière's Disease (PREDMEN Trial).
Run by Leiden University Medical Center · NCT05851508 · Data updated 2026-11-12
This study is testing whether injections of a medication called methylprednisolone can help people with Meniere's disease feel less dizzy compared to a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 148 (estimated) |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 1 site (Leiden, South Holland) |
| Status | Recruiting |
| Started | October 1, 2023 |
| Main results expected | May 1, 2026 |
| Study ends | February 1, 2027 |
| Registry record updated | December 4, 2023 |
| Trial ID | NCT05851508 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old with a confirmed diagnosis of unilateral Meniere's disease and experiencing at least four vertigo attacks in the past six months.
✕Probably not a fit
Patients with bilateral Meniere's disease or those who do not meet the specific diagnostic criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of intratympanic injections of methylprednisolone compared to placebo in patients with Meniere's disease, which causes episodes of vertigo, tinnitus, and hearing loss. The study will enroll 148 participants, randomly assigning them to receive either the active treatment or a placebo. Over the course of one year, the trial will assess the impact on dizziness, tinnitus, hearing loss, and overall quality of life through follow-up visits and telephone assessments. The aim is to provide clearer evidence on the efficacy of methylprednisolone for managing vertigo attacks in this patient population.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce vertigo attacks and improve the quality of life for patients with Meniere's disease.
How similar studies have gone: Previous studies have shown some promise with intratympanic corticosteroids, but this specific approach with methylprednisolone is still being evaluated for its effectiveness.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: • Unilateral, definite MD according to the diagnostic criteria derived from the American Academy Otolaryngology Head and Neck Surgery, Classification Committee of the Bárány Society, European Academy of Otology and Neurotology and International Classification of Vestibular Disorders published in 2015 \[7\] (see Appendix 1): Definite MD Two or more spontaneous episodes of vertigo, each lasting 20 minutes to 12 hours, AND Audiometrically documented low- to medium-frequency sensorineural hearing loss in one ear, defining the affected ear on at least one occasion before, during or after one of the episodes of vertigo, AND Fluctuating aural symptoms (hearing, tinnitus, or fullness) in affected ear (not better accounted for by another vestibular diagnosis) * age \> 18 years at the start of the trial. * ≥ 4 vertigo attacks over the last 6 months. * willing to adhere to daily trial medications and the follow-up assessments. Exclusion criteria A potential subject who meets any of the following criteria will be excluded: * bilateral MD * severe disability (e.g. neurological, orthopaedic, cardiovascular) or serious concurrent illness that might interfere with treatment or follow-up. * active additional neuro-otologic disorders that may mimic MD (e.g. vestibular migraine, recurrent vestibulopathy, phobic postural vertigo, vertebro-basilar TIAs, acoustic neuroma). * otitis media with effusion based on tympanogram results. * history of intratympanic injections with corticosteroid less than 6 months ago. * history of intratympanic injections with gentamicin or ear surgery for treating MD. * pregnant women and nursing women.
Where it's running
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Leiden University Medical Centre
Leiden, South Holland, Netherlands Recruiting
Study contacts
- Study coordinator: Maud Boreel, MD
- Email: m.m.e.boreel@lumc.nl
- Phone: +3171 526 9111
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Deep phenotyping of hearing instability disorders
This study tests how to classify and understand people with hearing fluctuations using MRI, blood tests, and hearing/balance tests.
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Using Anakinra to treat Meniere's Disease and Autoimmune Inner Ear Disease
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.